Kyle Hamer v. LIVANOVA DEUTSCHLAND GMBH, FKA Sorin Group Deutschland GMBH

PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
____________
Nos. 20-1656 & 20-1657
____________
KYLE HAMER,
Appellant
v.
LIVANOVA DEUTSCHLAND GMBH, FKA Sorin
Group Deutschland GMBH; LIVANOVA HOLDING USA,
Inc. FKA Sorin Group USA, Inc.
Appeal from the United States District Court
for the Middle District of Pennsylvania
(D.C. Civil Action Nos. 1-18-cv-01645 and
1-18-md-02816)
District Judge: Honorable John E. Jones, III
Argued on November 18, 2020
Before: AMBRO, BIBAS and ROTH, Circuit Judges
(Opinion filed: April 9, 2021)

-- 1 of 15 --

2
Lawrence J. Centola, III (ARGUED)
Jason Z. Landry
Martzell Thomas & Bickford
338 Lafayette Street
New Orleans, LA 70130
Counsel for Appellant
Mark J. Winebrenner (ARGUED)
Faegre Drinker Biddle & Reath
90 South Seventh Street
2200 Wells Fargo Center
Minneapolis, MN 55402
Jared B. Briant
Faegre Drinker Biddle & Reath
1144 15th Street, Suite 3400
Denver, CO 80202
Magda S. Patitsas
Adam M. Shienvold
Eckert Seamans Cherin & Mellott
213 Market Street, 8th Floor
Harrisburg, PA 17101
Counsel for Appellee

-- 2 of 15 --

3
O P I N I ON
ROTH, Circuit Judge:
Kyle Hamer appeals the order of the District Court for
the Middle District of Pennsylvania, dismissing with prejudice
his claims against Sorin Group, U.S.A., Inc., n/k/a LivaNova
Holding U.S.A., Inc., in Multidistrict Litigation case number
2816 (MDL 2816), and denying as moot his motion to remand
this case to the Eastern District of Louisiana. Hamer contends
that the District Court abused its discretion by dismissing his
case with prejudice solely for failure to comply with a specific
diagnostic requirement set out by a case management order.
We will reverse the dismissal order and remand this case to the
District Court with instructions to forward it to the Judicial
Panel on Multidistrict Litigation (JPML) for remand to the
Eastern District of Louisiana.
I.
A. Background
On July 20, 2017, Hamer underwent open heart surgery
at Children’s Hospital-New Orleans, using LivaNova’s 3T
Heater-Cooler System. He subsequently developed an
infection in the incision and returned to Children’s Hospital on
September 4. His physicians suspected that his infection
stemmed from a non-tuberculosis mycobacterium (NTM),
Mycobacterium abscessus. The hospital had experienced an

-- 3 of 15 --

4
outbreak of NTM infections in other patients who had
undergone surgery using the 3T System. Hamer was treated
for a suspected infection from September 4 to 25. His
treatment team never isolated NTM from any of the swabs or
cultures. His physician informed him that the lack of a positive
NTM culture did not mean that he hadn’t had an NTM
infection. Hamer now alleges that his treatment caused him
lasting injuries, including potential long-term hearing loss.
B. Procedural History
Hamer filed a complaint against LivaNova in the
Eastern District of Louisiana on July 18, 2018, asserting claims
under the Louisiana Products Liability Act (LPLA) for failure
to warn and inadequate design, among other violations. He
alleged that “after [his] open-heart surgery . . ., [he was] treated
for mycobacterium abscessus,” which led him to suffer
damages.1 The JPML transferred Hamer’s case to MDL 2816
on August 17, 2018, along with other cases alleging damages
from the NTM infection outbreak caused by the 3T System.2
1. CMO 15
On April 16, 2019, the District Court entered Case
Management Order 15 (CMO 15) to manage the proceedings
in remaining 3T cases that had not been settled pursuant to a
Master Settlement Agreement. CMO 15 required plaintiffs to
show, among other things, “proof of NTM infection” through
1 Joint Appendix (“JA”) 43–44.
2 See In re Sorin 3T Heater-Cooler Sys. Prods. Liab. Litig. (No. II),
289 F. Supp. 3d 1335 (J.P.M.L. 2018) (selecting the Middle District
of Pennsylvania as the transferee district).

-- 4 of 15 --

5
“positive bacterial culture results showing infection with [an
NTM] following surgery with a Sorin 3T.”3 It also required
plaintiffs to produce expert reports, showing general and
specific causation for their alleged injuries.
2. Dismissal Pursuant to CMO 15
Hamer did not comply with CMO 15 in time. LivaNova
filed a Motion for Issuance of a Rule to Show Cause, seeking
dismissal of Hamer’s claims for failure to comply with the
order. As a result, the District Court entered an Order to Show
Cause why Hamer’s case should not be dismissed with
prejudice for (1) failure to produce a positive bacterial culture
result showing infection with NTM, (2) failure to produce a
case-specific expert report concerning the causation of
Hamer’s alleged injury and alternative causation, and (3)
failure to produce all relevant medical records.4 Hamer
opposed the order, claiming his complaint did not warrant
dismissal because it stated a prima facie claim under Louisiana
law. He filed a motion to remand his case to the Eastern
District of Louisiana. On March 19, 2020, the court dismissed
Hamer’s claims with prejudice on the basis that Hamer lacked
proof of an NTM infection and denied his motion to remand as
3 Joint Appendix (“JA”) 16. CMO 15 provided that plaintiffs who
failed to meet the order’s requirements would be served with an
Order to Show Cause why their cases should not be dismissed. If
plaintiffs failed to show cause within 21 days, their cases would be
dismissed with prejudice.
4 LivaNova does not dispute that Hamer provided medical records
pursuant to CMO 15 and does not argue that his case should be
dismissed for failure to produce medical records; rather, it argues
that Hamer’s records are deficient because they do not show proof
of an NTM infection.

-- 5 of 15 --

6
moot. In relevant part, its two-page opinion reads as follows:
Hamer . . . argues that this matter should be
remanded to the Eastern District of Louisiana for
resolution of his claims on the basis that,
although mycobacterium was never isolated
from any of the swabs or cultures from his
infection, his [wound] was suspicious for
mycobacterial infection and was treated as such.
On this basis, Hamer seems to believe he still
[has] a claim to pursue against the Defendant.
Unfortunately for Hamer, the language of CMO
15 is starkly clear and unavoidable—a plaintiff
must have positive bacterial culture results
showing infection with a non-tuberculosis
mycobacteria [sic] following surgery with a
Sorin 3T to proceed as a litigating Plaintiff in this
multi-district litigation. Accordingly, because
Plaintiff has acknowledged that he does not have
proof of an NTM infection, he has failed to show
cause pursuant to our December 19, 2020 Order
why this matter should not be dismissed with
prejudice.5
Hamer appealed the District Court’s dismissal and its
denial of his motion to remand.
II.
We review involuntary dismissals under Rule 41(b) of
5 JA 9–10 (internal quotation marks omitted).

-- 6 of 15 --

7
the Federal Rules of Civil Procedure6 for abuse of discretion.7
While we take into account MDL judges’ “increased burden”
when applying the abuse of discretion standard, the fact that a
proceeding occurred in a MDL setting “does not alter the
substantive rights of the litigants.”8 Although we defer to the
District Court’s discretion, “dismissals with prejudice . . . are
drastic sanctions,”9 “only appropriate in limited
circumstances[,] and doubts should be resolved in favor of
reaching a decision on the merits.”10 We exercise plenary
review over a district court’s denial of a motion to remand.11
III.
Hamer argues that the District Court abused its
discretion by dismissing his claims with prejudice solely
because he could not produce proof of a positive NTM culture.
He claims that, by requiring all plaintiffs in MDL 2816 to show
evidence of a specific infection, the District Court fashioned an
ad hoc substantive criterion for participation in the MDL,
6 District courts have authority under Rule 41(b) of the Federal Rules
of Civil Procedure to dismiss claims with prejudice for failure to
comply with a court order. The District Court’s order did not state
whether dismissal of Hamer’s claims was pursuant to its authority
under Rule 41(b), but both parties agree that the order was a Rule
41(b) dismissal. Therefore, we will proceed on that basis.
7 Emerson v. Thiel College, 296 F.3d 184, 190 (3d Cir. 2002).
8 In re Asbestos Prods. Liab. Litig. (No. VI), 718 F.3d 236, 243 (3d
Cir. 2013).
9 Poulis v. State Farm Fire & Cas. Co., 747 F.2d 863, 867 (3d Cir.
1984).
10 Emerson, 296 F.3d at 190 (citing Adams v. Trs. of the N.J.
Brewery Emps. Pension Tr. Fund, 29 F.3d 863, 870 (3d Cir. 1994)).
11 USX Corp. v. Adriatic Ins. Co., 345 F.3d 190, 199 (3d Cir. 2000)
(citation omitted).

-- 7 of 15 --

8
which should not have a basis for dismissing his claims with
prejudice before considering whether meeting it was necessary
to state a claim under Louisiana law. In other words, Hamer
claims that the dismissal of his suit with prejudice hobbled his
ability to proceed in any court under a theory of injury that,
while perhaps too factually distinct from other 3T-related cases
to remain in MDL 2816, may still state a prima facie claim
against LivaNova. We agree and conclude that the District
Court abused its discretion.
CMO 15 is an example of a Lone Pine order, by which
trial courts require plaintiffs to produce threshold prima facie
support for their claims, such as expert reports and medical
records.12 Lone Pine orders are routinely used by courts to
streamline litigation in mass tort cases.13 Hamer does not
challenge the propriety of CMO 15 or Lone Pine orders
generally and does not seek to modify CMO 15 as applied to
all participants. Instead, he contends that the dismissal of his
claims with prejudice for failure to have a positive result for
NTM is beyond an MDL Court’s authority under FRCP 41(b).
As an initial matter, we do not believe that the District
Court abused its discretion by entering CMO 15 or by
including among its provisions a requirement that plaintiffs
produce a positive NTM culture. A district court,
12 See Lore v. Lone Pine Corp., 1986 WL 637507, at *4 (N.J. Super.
Ct. Law Div. Nov. 18, 1986) (unpublished) (upholding case
management order, finding that “prior to the institution of [a mass
tort action], attorneys for plaintiffs must be prepared to substantiate,
to a reasonable degree, the allegations of personal injury, property
damage and proximate cause”).
13 In re Vioxx Prods. Liab. Litig., 557 F. Supp. 2d 741, 743 (E.D.
La. 2008) (collecting cases).

-- 8 of 15 --

9
administrating a multidistrict case, faces unique challenges not
present when administrating cases on a routine docket.14 As
such, in the MDL context, we conclude that district courts must
be granted significant latitude to manage their dockets and to
mitigate “potential burdens on the defendants and court.”15 In
an MDL case, management orders are essential tools in helping
the court weed out non-meritorious or factually distinct claims.
Accordingly, an MDL court “needs to have broad discretion to
. . . keep[] the parts in line” by entering Lone Pine orders that
“drive[] disposition on the merits.”16 Such orders may impose
preliminary discovery requirements, like the production of
relevant expert reports, or may require plaintiffs to furnish
specific evidence like proof of a medical diagnosis, with the
goal of winnowing non-compliant cases from the MDL. That
said, “efficiency must not be achieved at the expense of
preventing meritorious claims from going forward.”17
Here, the District Court would have acted within its
discretion if it had dismissed Hamer’s claims without prejudice
for failure to comply with CMO 15’s NTM infection
requirement, or if it had suggested remand to the transferor
court. The court would even have been within its discretion to
dismiss Hamer’s claims with prejudice, provided that it
properly found that Hamer had not stated a prima facie case for
relief under Louisiana law.18 But that is not what happened.
14 In re Asbestos (No. VI), 718 F.3d at 246 (citing In re
Phenylpropanolamine (PPA) Prods. Liab. Litig., 460 F.3d 1217,
1229 (9th Cir. 2006)).
15 Id. (quoting Acuna v. Brown & Root, Inc., 200 F.3d 335, 340–41
(5th Cir. 2000)).
16 Id. at 247 (quoting In re PPA, 460 F.3d at 1232).
17 Id.
18 See, e.g., In re Korean Air Lines Co., Ltd., 642 F.3d 685, 699 (9th

-- 9 of 15 --

10
The District Court dismissed Hamer’s claims with prejudice
and without any discussion of whether, in order to allege a
redressable injury, the claims must be predicated on proof of
an NTM infection. The court was well within its discretion to
find that Hamer’s claims may be too factually distinct to
continue in MDL 2816. However, by dismissing his claims
with prejudice, it deprived Hamer of the opportunity to litigate
his claims in any venue without consideration of how they
might fare outside the MDL context. More is required before
a court should wholly extinguish a claim.19
Indeed, Hamer’s case may have merit under Louisiana
law. The infection may have been caused by another organism
Cir. 2011) (concluding that while MDL courts have jurisdiction over
pre-trial proceedings including motions to dismiss, they are bound
by the same substantive standards as the transferor court); David F.
Herr, Multi-District Litig. Manual § 9:18 (2014) (“The Panel has
recognized that the transferee court will be obligated to apply the
law the transferor forum would apply.”); see generally Van Dusen
v. Barrack, 376 U.S. 612, 639 (1964).
19 LivaNova cites our decision in In re Asbestos (No. VI), in which
we upheld the dismissal of three plaintiffs in an MDL for failure to
produce diagnostic information in response to a Lone Pine order, as
support for affirming Hamer’s dismissal. See 718 F.3d at 245–46.
But Asbestos’ Lone Pine finding is distinguishable. In that case, we
affirmed the plaintiffs’ dismissals only after the district court had
analyzed whether the diagnostic requirement at issue was necessary
to state a claim under the relevant state law. See id.; see also In re
Asbestos Prods. Liab. Litig. (No. VI), 278 F.R.D. 126, 133–35 (E.D.
Pa. 2011). Further, the only Asbestos plaintiff to challenge his
dismissal for failure to meet the CMO’s diagnostic requirement
argued merely that he did in fact meet the requirement, not that
dismissal for failure to meet the requirement constituted legal error.
See 718 F.3d at 245.

-- 10 of 15 --

11
or a Mycobacterium abscessus infection may have been
eradicated by immediate treatment before a culture was taken.
In addition, Hamer complained of injuries arising from an
overly-long course of antibiotics. 20
These allegations may be sufficient to state a claim
under the LPLA, which “establishes the exclusive theories of
liability for manufacturers for damage caused by their
products” in Louisiana.21 A product is
“unreasonably dangerous” under the LPLA if it is
unreasonable in construction or design or because of an
inadequate warning.22 Here, Hamer alleges that older versions
of the Sorin 3T suffered from design defects that made them
unreasonably dangerous and that newer models accommodated
a safer disinfection system that was not used in Hamer’s
surgery. Under the LPLA, these facts might state a prima facie
case for defective design.23
20 LivaNova argues that Hamer pleaded injury in the form of a
Mycobacterium abscessus infection in his Plaintiff Fact Sheet, in
which he was asked to identify the pathogen that “caused the
infection that is the subject of this lawsuit.” We are unconvinced.
Such an open-ended question does not foreclose Hamer’s theory that
his damages were caused by the hospital’s outbreak of, and Hamer’s
subsequent treatment for, Mycobacterium abscessus. And, in
response to another query on his Plaintiff Fact Sheet, Hamer
explained that his injuries stemmed from the reopening of his chest
incision for treatment and the injection of oral antibiotics for a
prolonged period.
21 La. R.S. § 9:2800.52.
22 La. R.S. §§ 9:2800.54–57.
23 As LivaNova correctly points out, Hamer raised a number of
novel theories in opposing the District Court’s Order to Show Cause
(and in his opening brief before this Court) that are absent from his
complaint, including “fear of infection” and negligent infliction of

-- 11 of 15 --

12
In sum, Hamer presents alternative and potentially
redressable theories of injury against LivaNova. Hamer’s
allegations may diverge from those of other cases in MDL
2816 in which an NTM infection was verified. Nevertheless,
stating alternative theories of liability cannot justify slamming
the door on his claims. For this reason, we will reverse the
District Court’s order dismissing Hamer’s claims with
prejudice for failure to produce a positive NTM culture.24 25
emotional distress. Because those claims were not raised in his
complaint, we cannot consider them now as a basis for appeal. See
Sansom Comm. v. Lynn, 366 F. Supp. 1271, 1278 (E.D. Pa. 1973)
(“The proper means of raising claims that have inadvertently not
been raised in the complaint is an amended complaint[.]”).
24 CMO 15 also required plaintiffs to furnish expert reports showing
specific and general causation for their injuries. Although the
District Court ordered Hamer to show cause why he had not
produced an expert report on specific causation, it ultimately
dismissed Hamer’s claims based solely on his failure to meet the
NTM culture requirement without discussing whether the specific
causation report requirement had been met. Therefore, we express
no opinion as to the adequacy of Hamer’s expert discovery
submission or whether the District Court would have erred by
dismissing his claims for failure to comply with CMO 15’s expert
report requirement.
25 District courts must ordinarily consider the six factors laid out by
Poulis v. State Farm Fire and Casualty Co., 747 F.2d 863, 868 (3d
Cir. 1984), before dismissing a case by court order under Rule
41(b). See United States v. $8,221,877.16 in U.S. Currency, 330
F.3d 141, 161–62 (3d Cir. 2003); Briscoe v. Klaus, 538 F.3d 252,
258 (3d Cir. 2008). The District Court was required to undertake at
least some consideration of the Poulis factors before dismissing
Hamer’s claims, but did not do so. That, in addition to the reasons
discussed, was an abuse of discretion. Since the District Court did
not analyze the Poulis factors, we need not consider whether they

-- 12 of 15 --

13
IV.
Having determined that the District Court abused its
discretion in dismissing Hamer’s claims with prejudice, we
turn to the question of remedy. Hamer wishes to continue
litigating his claims, not in the Middle District of Pennsylvania
as part of MDL 2816, but in the Eastern District of Louisiana,
where the claims were first brought. At the time that the
District Court issued its order to show cause why Hamer’s case
should not be dismissed, he filed a remand motion to this
effect. The District Court denied this motion as moot after
dismissing his claims with prejudice. On appeal, Hamer
requests that we reverse the District Court’s denial of his
remand motion and order the District Court to suggest to the
JPML that it accept the remand.
As we discuss in Part III, we will reverse. As for
remand, the District Court did not get to Hamer’s arguments in
favor of remand because it had already dismissed his claims
with prejudice for failure to comply with CMO 15. Now,
however, remand is appropriate and the JPML is the proper
destination for it to consider remand back to the Eastern
District of Louisiana. Under 28 U.S.C. § 1407(a), the JPML
has authority to remand a case that had been transferred into a
consolidated proceeding “at or before the conclusion of . . .
pretrial proceedings.” Once an action has been transferred into
an MDL, “a party seeking remand to the transferor court has
the burden of establishing that such remand is warranted.”26
support dismissal here. If Hamer’s claims are again dismissed under
Rule 41(b) on remand, fuller consideration of Poulis is needed.
26 In re Integrated Res., Inc. Real Est. Ltd. P’ship Sec. Litig., 851
F. Supp. 556, 562 (S.D.N.Y. 1994) (citing In re Holiday Magic
Sec. & Antitrust Litig., 433 F. Supp. 1125, 1126 (J.P.M.L. 1977)).

-- 13 of 15 --

14
The JPML has discretion to remand before pretrial proceedings
have concluded when doing so “will serve the convenience of
the parties and witnesses and will promote the just and efficient
conduct of [the litigation],”27 or when “everything that remains
to be done is case-specific.”28 “Generally, the decision to
remand turns on the question of whether the case will benefit
from further coordinated proceedings as part of the MDL,”29
and remand is appropriate when the transferee court has
determined that its “role in the case has ended.”30 An MDL
court may not issue a remand directly,31 but its suggestion to
the JPML whether or not a case should be remanded is afforded
“great weight.”32 The JPML is “reluctant to order a remand
absent [a] suggestion of the transferee judge,”33 but, even if the
transferee court suggests remand, the JPML will only follow
27 In re Air Crash Disaster at Tenerife, 461 F. Supp. 671, 672
(J.P.M.L. 1978)).
28 Id.; see also In re Wilson, 451 F.3d 161, 172 (3d Cir. 2006) (noting
that “when remand is sought before the conclusion of coordinated
or consolidated pretrial proceedings, the JPML’s authority is
discretionary.”)
29 In re Baycol Prods. Litig., 265 F.R.D. 453, 455 (D. Minn. 2008)
(internal quotation marks omitted) (citing Air Crash Disaster, 461
F. Supp. at 672–73).
30 In re Integrated Res., 851 F. Supp. at 562 (citation omitted).
31 See Lexecon, Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523
U.S. 26, 41 n.4 (1998) (“[W]e find that the statutory language of §
1407 precludes a transferee court from granting any 1404(a) motion
. . ..”); Kalama v. Matson Nav. Co., Inc., 875 F.3d 297, 308 (6th Cir.
2017) (finding that an MDL court’s direct transfer to another district
court would “thwart the JPML’s ability to remand to the originating
court[.]”).
32 Patenaude, 210 F.3d at 141.
33 RULES OF PROC. OF THE U.S. JUD. PANEL ON MULTIDISTRICT
LITIG., Rule 10.3(a).

-- 14 of 15 --

15
its suggestion if good cause for remand is shown.34
The circumstances of Hamer’s case indicate good cause
for granting his request. CMO 15 was entered pursuant to the
District Court’s “inherent authority to manage” any remaining
cases against LivaNova existing after “the [Master Settlement
Agreement] entered after years of litigation.”35 The District
Court was within its discretion to do so. Indeed, we agree that
Hamer’s case was ill-suited for continued consolidation: his
alternate theories of liability raise questions of causation and
injury not present where a plaintiff had a positive NTM
culture.36 When the District Court determined it could no
longer efficiently administer Hamer’s claims, it should have
suggested to the JPML that the case be remanded in order to
return it to Louisiana. For that reason, we will reverse the
District Court’s denial of Hamer’s motion to remand and
instruct the District Court to suggest to the JPML that it remand
Hamer’s case to the Eastern District of Louisiana.
V.
For the foregoing reasons, we will reverse the judgment
of the District Court and remand for further proceedings
consistent with this opinion.
34 In re S. Cent. States Bakery Prods. Antitrust Litig., 462 F. Supp.
388, 390 (J.P.M.L. 1978) (citation omitted).
35 JA 11.
36 See Wilson, 451 F.3d at 170 (“[T]he test is not whether
proceedings on issues common to all cases have concluded; it is
whether the issues overlap[.]”).

-- 15 of 15 --